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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209406
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209406Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

BRINZOLAMIDE

SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZOPT BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription Yes AB 020816 NOVARTIS
BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 204884 BAUSCH AND LOMB
BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS;OPHTHALMIC Prescription No AB 209406 WATSON LABS INC
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